Recall Z-3022-2017— GE Medical Systems, LLC
Class II · Terminated
Class II FDA medical device recall by GE Medical Systems, LLC, initiated 2017-05-11, terminated 2020-09-09. It names 4 FDA 510(k) clearances: K160618, K142085, K132376 and 1 more. Product: Optima MR450 1.5T Product Usage: 1 .5T Brivo MR355 and 1.5T Optima MR360 are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the 1 .5T Brivo MR355 and I .5T Optima MR360 reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.. Reason: Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard..
- Recalling firm
- GE Medical Systems, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-05-11
- Terminated
- 2020-09-09
- Firm location
- Waukesha, WI, United States
510(k) clearances named in this recall
4 on FDA's record- K160618 — Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T
- K142085 — DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 3.0T,OPTIMA MR450W 1.5T
- K132376 — DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T
- K083147 — DISCOVERY MR450
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Optima MR450 1.5T Product Usage: 1 .5T Brivo MR355 and 1.5T Optima MR360 are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the 1 .5T Brivo MR355 and I .5T Optima MR360 reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
Reason for recall
Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
Data sourced from openFDA. This site is unofficial and independent of the FDA.